The present invention relates to the processing of signals obtained from a medical diagnostic apparatus such as a pulse oximeter using a blind source separation technique to separate the obtained data without prior knowledge of its magnitude or frequency into data corresponding to the desired physiological data and the undesired interference sources.
A typical pulse oximeter measures two physiological parameters, percent oxygen saturation of arterial blood hemoglobin (SpO2 or sat) and pulse rate. Oxygen saturation can be estimated using various techniques. In one common technique, the photocurrent generated by the photo-detector is conditioned and processed to determine the ratio of modulation ratios (ratio of ratios) of the red to infrared signals. This modulation ratio has been observed to correlate well to arterial oxygen saturation. The pulse oximeters and sensors are empirically calibrated by measuring the modulation ratio over a range of in vivo measured arterial oxygen saturations (SaO2) on a set of patients, healthy volunteers, or animals. The observed correlation is used in an inverse manner to estimate blood oxygen saturation (SpO2) based on the measured value of modulation ratios of a patient. The estimation of oxygen saturation using modulation ratios is described in U.S. Pat. No. 5,853,364, entitled “METHOD AND APPARATUS FOR ESTIMATING PHYSIOLOGICAL PARAMETERS USING MODEL-BASED ADAPTIVE FILTERING”, issued Dec. 29, 1998, and U.S. Pat. No. 4,911,167, entitled “METHOD AND APPARATUS FOR DETECTING OPTICAL PULSES”, issued Mar. 27, 1990. The relationship between oxygen saturation and modulation ratio is further described in U.S. Pat. No. 5,645,059, entitled “MEDICAL SENSOR WITH MODULATED ENCODING SCHEME,” issued Jul. 8, 1997. Most pulse oximeters extract the plethysmographic signal having first determined saturation or pulse rate, both of which are susceptible to interference.
A challenge in pulse oximetry is in analyzing the data to obtain a reliable measure of a physiologic parameter in the presence of large interference sources. Prior art solutions to this challenge have included methods that assess the quality of the measured data and determine to display the measured value when it is deemed reliable based upon a signal quality. Another approach involves a heuristic-based signal extraction technology, where the obtained signals are processed based on a series of guesses of the ratio, and which require the algorithm to start with a guess of the ratio, which is an unknown. Both the signal-quality determining and the heuristic signal extraction technologies are attempts at separating out a reliable signal from an unreliable one, one method being a phenomenological one and the other being a heuristic one.
On the other hand, a problem encountered in such disciplines as statistics, data analysis, signal processing, and neural network research, is finding a suitable representation of multivariate data. One such suite of methods is generally known as Independent Component Analysis (ICA), which is an approach to the problem of Blind Source Separation (BSS).
In general terms, the goal of blind source separation in signal processing is to recover independent source signals after they are linearly mixed by an unknown medium, and recorded or measured at N sensors. The blind source separation has been studied by researchers in speech processing or voice processing; antenna array processing; neural network and statistical signal processing communities (e.g. P. Comon, “Independent Component Analysis, a New Concept?”, Signal Processing, vol. 36. no. 3, (April 1994), pp. 287–314, “Comon”) and applied with relative degrees of success to electroencephalogram data and functional MRI imaging.
Comon defined the concept of independent component analysis as maximizing the degree of statistical independence among outputs using “contrast” functions of higher-order cumulants. Higher-order statistics refer to the expectations of products of three or more signals (e.g. 3rd-order or 4th-order moments), and cumulants are functions of the moments which are useful in relating the statistics to those of the Gaussian distribution. The 3rd-order cumulant of a distribution is called a skew, and the 4th-order cumulant is the kurtosis. A contrast function is any non-linear function which is invariant to permutation and scaling matrices, and attains its minimum value in correspondence of the mutual independence among the output components. In contrast with decorrelation techniques such as Principal Component Analysis (PCA), which ensures that output pairs are uncorrelated, ICA imposes the much stronger criterion that the multivariate probability density function of output variables factorizes. Finding such a factorization requires that the mutual information between all variable pairs go to zero. Mutual information depends on all higher-order statistics of the output variables while decorrelation normally only takes account of 2nd-order statistics.
While the general use of ICA as a means of blindly separating independent signal sources is known, the method poses unique challenges to its implementation in pulse oximetry. For instance, the mixture signals may not be exactly a linear combination of the pulse signal and sources of interference. Also, most ICA techniques are based on fourth-order cumulants, as the signals and noise commonly encountered in communications have zero third-order cumulant (skew), and cumulants of higher than fourth order are difficult to estimate accurately.
Several ICA methods are known for separating unknown source signals from sets of mixture signals, where the mixture signals are a linear combination of the source signals. As used in pulse oximetry, the mixture signals refer to signals measured at multiple wavelengths. Source components refer to the desired physiologic data including signals corresponding to the plethysmographic signal obtained at multiple wavelengths in addition to undesired interference data, which may be caused by motion, light interference, respiratory artifacts, and other known sources of errors in pulse oximetry.
There is therefore a need to apply blind source separation techniques to the field of pulse oximetry to be able to deterministically separate a source signal from various interference sources.